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RECRUITING
NCT05230745
NA

ContraBand™: Safety & Feasibility Study (RM-20-01)

Sponsor: Restore Medical Ltd

View on ClinicalTrials.gov

Summary

ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in a lower distal systolic pulmonary artery pressure (PAP) as well as an attenuation in the rise of the mean pulmonary capillary wedge pressure (PCWP) along with a higher pulmonary arterial compliance (PAC) distal to the constriction during exercise. Lower PCWP reflects the reduced left ventricular end diastolic pressure (LVEDP), contributing to enhanced ventricular filling and improved cardiac output. This hemodynamic change is anticipated to translate into enhanced physical capacity and a potentially more favorable prognosis for heart failure subjects. This study is an early feasibility, multi center, prospective, interventional, open-label, single-arm study.

Official title: ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2021-09-28

Completion Date

2032-12-31

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DEVICE

ContraBand implants

Percutaneous implantation of the ContraBand devices by right heart catheterization

Locations (12)

Clinical Site

Aalst, Belgium

Clinical Site

Antwerp, Belgium

Clinical Site

Genk, Belgium

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Clinical Site

Lübeck, Germany

Clinical Site

Nahariya, Israel

Clinical Site

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

Clinical Site

Klaipėda, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Clinical Site

Krakow, Poland

Clinical Site

Lublin, Poland